Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clarifying Optimal Sodium Intake Project (COSIP-1)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02738736
Recruitment Status : Unknown
Verified September 2018 by Dr Andrew Smyth, University College Hospital Galway.
Recruitment status was:  Active, not recruiting
First Posted : April 14, 2016
Last Update Posted : September 7, 2018
Sponsor:
Collaborators:
European Research Council
National University of Ireland, Galway, Ireland
Information provided by (Responsible Party):
Dr Andrew Smyth, University College Hospital Galway

Brief Summary:
Hypertension is a leading risk factor for cardiovascular disease (CVD) globally, accounting for 25-35% of the population-attributable fraction. Sodium (salt) intake is a key determinant of blood pressure, and reducing sodium intake has emerged as an important target for population-based interventions to prevent CVD. However, there is considerable uncertainty about the optimal level of sodium intake that is associated with lowest CV risk, and whether optimal levels differ for different populations and individuals. International and national guidelines recommend low sodium intake (<2.3g/day, or lower) in all persons, and advocate a population-wide approach to reducing sodium. Most of the world's population (~95%) consume between 3 and 6g/day of sodium (mean intake 4.0g/day), which means that most people will require a major change to their diet, to achieve the guideline target (<2g/day). While there is convincing evidence that high sodium intake (>5g/day) is associated with an increased risk of CVD, compared to low or moderate intake, the evidence that low sodium intake (<2.0g/day) is associated with a lower risk of CVD than moderate intake (2.0-5g/day) is inconsistent and inconclusive. The investigators plan to conduct a Phase IIb clinical trial to evaluate the role of low sodium intake (versus moderate) on cardiovascular biomarkers.

Condition or disease Intervention/treatment Phase
Blood Pressure Hypertension Kidney Disease Cardiovascular Disease Behavioral: Sodium Reduction Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 269 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clarifying Optimal Sodium Intake Project- Objective 1
Study Start Date : April 2016
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium Reduction
In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day).
Behavioral: Sodium Reduction
In addition to usual care, those randomised to the intervention arm will receive specific counseling on behavioural and environmental factors that promote sodium reduction after randomization and at all specified post-randomisation visits, targeting sodium intake of <100mmol/day (<2.3g/day). A research dietitian will develop the specific components of the intervention, based on standardised approaches to education interventions

No Intervention: Usual Care
Participants randomized to usual care will also attend a dietitian-developed healthy eating guidance session but will not receive specific recommendations targeting sodium intake.



Primary Outcome Measures :
  1. Change in cardiovascular biomarkers (Renin) [ Time Frame: 24 months ]
    Change in renin from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

  2. Change in cardiovascular biomarkers (Aldosterone) [ Time Frame: 24 months ]
    Change in aldosterone from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

  3. Change in cardiovascular biomarkers (Troponin T) [ Time Frame: 24 months ]
    Change in troponin T from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

  4. Change in cardiovascular biomarkers (Pro-BNP) [ Time Frame: 24 months ]
    Change in Pro-BNP from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).

  5. Change in cardiovascular biomarkers ( C-reactive protein) [ Time Frame: 24 months ]
    Change in C-reactive protein from baseline to final follow-up, measured from serum measurements taken at randomisation and final visit (T8).


Secondary Outcome Measures :
  1. Change in 24-hour urinary sodium excretion [ Time Frame: 24 months ]
    Change in 24-hour urinary sodium excretion from baseline to final visit (two years)

  2. Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring [ Time Frame: 24 months ]
    Change in mean systolic and diastolic blood pressure from 24-hour ambulatory blood pressure monitoring completed at baseline and final visit (two years)

  3. Change in functional status as measured by the assessment functional status questionnaire [ Time Frame: 24 months ]
  4. Change in eGFR (MDRD formula) [ Time Frame: 24 months ]
    Change in eGFR (MDRD formula) from baseline to final follow-up

  5. Change in eGFR(CKD-EPI formula) [ Time Frame: 24 months ]
    Change in eGFR (CKD-EPI formula) from baseline to final follow-up

  6. Change in RNA measured through PAXgene RNA blood samples [ Time Frame: 24 months ]
  7. Number of recorded falls, syncope and pre-syncope [ Time Frame: 24 months ]
  8. Number of cardiovascular events [ Time Frame: 24 months ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 40 years or older
  • Systolic blood pressure <160mmHg and diastolic blood pressure <95mmHg on three office blood pressure readings at time of screening and confirmed by a study ABPM before randomization of <150/90mmHg
  • No change in anti-hypertensive or diuretic medications (including dose) for 3 months before screening visit
  • Consumption of moderate sodium intake at screening, defined as an estimated daily sodium intake of >2.3/day estimated from food frequency questionnaire (FFQ)
  • Self-reported willingness to modify dietary intake over sustained period, and adhere with directed recommendations over 2 years.
  • Signed written informed consent

Exclusion Criteria:

  • Known chronic kidney disease (CKD) or most recent eGFR ≤60ml/min/1.73m2
  • Participants who are ineligible for COSIP based on their eGFR will be approached about entering the ongoing Sodium Intake in Chronic Kidney Disease (STICK) trial.
  • Previous cardiovascular disease:

    • Myocardial infarction
    • Previous percutaneous coronary intervention (PCI) or percutaneous transluminal coronary angioplasty (PTCA)
    • Stroke (previous transient ischaemic attack [TIA] is not an exclusion criterion)
  • Medical diagnosis known to be associated with abnormal renal sodium excretion, including the following:

    • Bartter syndrome
    • SIADH
    • Diabetes insipidus
  • Serum sodium <125mmol
  • Severe heart failure defined as NYHA Class III/IV OR left ventricular ejection fraction (LVEF) ≤30%
  • High-dose loop or thiazide diuretic therapy, exceeding a total daily dose of frusemide 80mg, bumetanide 2mg, hydrochlorothiazide 50mg, bendroflumethiazide 2.5mg, indapamide 2.5mg, metolazone 2.5mg or the use of both a loop and thiazide diuretic
  • Unable to follow educational advice of the research team
  • Prescribed high-salt diet, low-salt diet or sodium bicarbonate
  • Symptomatic postural hypotension or receiving treatment for postural hypotension
  • Current or recent use (within one month) of immunosuppressive medications including tacrolimus, cyclosporine, azathioprine or mycophenolate mofetil
  • Pregnancy or lactation
  • Unable to comply with 24-hour urinary collections, or medical condition making collection of 24-hour urinary collection difficult (e.g. severe urinary incontinence)
  • Participant unlikely to comply with study procedures or follow-up visits due to severe comorbid illness or other factor (e.g. inability to travel for follow-up visits, drug or alcohol misuse) in the opinion of the research team
  • Cognitive impairment defined as a known diagnosis of dementia or inability to provide informed consent due to cognitive impairment in the opinion of the investigator
  • Body Mass Index (BMI) <20 kg/m2 or BMI>40 kg/m2
  • Participating in another clinical trial or previous allocation in this study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738736


Locations
Layout table for location information
Ireland
HRB Clinical Research Facility Galway
Galway, Ireland
Sponsors and Collaborators
University College Hospital Galway
European Research Council
National University of Ireland, Galway, Ireland
Investigators
Layout table for investigator information
Principal Investigator: Martin J O'Donnell, MB PhD MRCPI National University of Ireland, Galway
Principal Investigator: Andrew Smyth, MB PhD National University of Ireland, Galway
Layout table for additonal information
Responsible Party: Dr Andrew Smyth, Dr., University College Hospital Galway
ClinicalTrials.gov Identifier: NCT02738736    
Other Study ID Numbers: HRBCRFG-010416
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: September 7, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Cardiovascular Diseases
Urologic Diseases